WHO good manufacturing practices for active pharmaceutical ingredients

1. Introduction:

1.1 Objective:

This document (guide) is intended to provide guidance regarding good manufacturing practices (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.

In this guide “manufacturing” is defined to include all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls. In this guide the term “should” indicates recommendations that are expected to apply unless shown to be inapplicable or replaced by an alternative demonstrated to provide at least an equivalent level of quality assurance. For the purposes of this guide, the terms “current good manufacturing practices” and “good manufacturing practices” are equivalent.

The guide as a whole does not cover safety aspects for the personnel engaged in the manufacture, nor aspects of protection of the environment. These controls are inherent responsibilities of the manufacturer and are governed by national laws.

This guide is not intended to define registration and fi ling requirements or modify pharmacopoeial requirements. This guide does not affect the ability of the responsible regulatory agency to establish specific registration or fi ling requirements regarding APIs within the context of marketing or manufacturing authorizations or pharmaceutical applications. All commitments in registration and fi ling documents must be met.

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Table of contents

1. Introduction

2. Quality management

3. Personnel

4. Buildings and facilities

5. Process equipment

6. Documentation and records

7. Materials management

8. Production and in-process controls

9. Packaging and identification labelling of APIs and intermediates

10. Storage and distribution